Field Safety Notices (FSNs): 11/08/25 – 15/08/25

Manufacturers’ Field Safety Notices

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General list (internal)

DL7 General list (external)

Outlook tags     IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)

This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.

This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.

You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.

Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).

Section 1: estates, facilities or general products

1.     Child safety: small hazards, big harm

2.     Product Recall: Erborian Centella Cream 50ml and 20ml (2508-0008)

Section 2: medical devices 11/08/25 – 15/08/25

1. Derma Sciences: Medihoney Date: 5 August 2025 Description: Medical-honey liquid barrier dressing, sterile MHRA reference: 36416410 2025/007/031/601/023
2. Dexcom: Dexcom One, Dexcom G7, and Dexcom One+ Receivers Date: 18 July 2025 Description: Percutaneous glucose monitoring system MHRA reference: 36420524 2025/005/015/601/065
3. Max Mobility: SpeedControl Dial used with the Smartdrive MX2+: Updated FSN to supersede 2024/012/011/601/079 (36354122) Date: 12 August 2025 Description: Manual wheelchair, power assist unit Model: MX2-3DC MHRA reference: 36431492
4. Olympus: TJF-Q190V Evis Exera III Duodenovideoscope TJF-Q290V Evis Lucera Elite Duodenovideoscope TJF-Q170V Duodenovideoscope Date:14 May 2025 Description: Flexible video duodenoscope, reusable Model: TJF-Q190V, TJF-Q290V, TJF-Q170V MHRA reference: 36443422
5. Orthofix: HALF PIN L120MM D4.0MM THREAD D4.0XL18MM PACK OF 2 Date: 25 July 2025 MHRA reference: 36416572 2025/007/025/601/077
6. Shenzhen Mindray bio-medical electronics: Patient Monitor Date: 11 August 2025 Model: BeneVision N1 MHRA reference: 36429373 2025/008/011/601/047
7. Siemens Healthcare: 3 Tesla MRI system Date: 05 August 2025 Description: MRI system, full body MHRA reference: 36415735 2025/008/008/601/052 FSN MHRA reference: 36415735 2025/008/008/601/052 Acknowledgment of Receipt
8. Siemens: ARTIS pheno Date: August 2025 Description: Stationary angiographic x-ray system, digital MHRA reference: 36462683 2025/008/008/601/057
9. Stryker: System 6/7/8/9 Reciprocating / Sternum Saw Date: 06 March 2025 MHRA reference: 36435194 2025/004/004/601/051
10. Waldemar Link: Endo-Model – M, GEMINI SL, CustomLINK Date: 08 August 2025 Description: Uncoated knee tibia/insert prosthesis Model: 15-2814/0315-2815/11318-316/0311C009635313-0583411C009405313-08644 MHRA reference: 36414418 2025/008/008/601/058

The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here. 

Section 3: updates and changes to previously published medical device FSNs

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:

• Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
• In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
• Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
• Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
• Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons

We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026

FAC406-212, 8B(i), Rev 7

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